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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Electrical, Transcutaneous, For Arthritis
510(k) Number K142236
Device Name BioniCare Hand System
Applicant
Vision Quest Industries, Inc.
1390 Decision St., Suite A
Vista,  CA  92081
Applicant Contact MOHAMED OUERGHI
Correspondent
Vision Quest Industries, Inc.
1390 Decision St., Suite A
Vista,  CA  92081
Correspondent Contact MOHAMED OUERGHI
Regulation Number882.5890
Classification Product Code
NYN  
Date Received08/13/2014
Decision Date 03/23/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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